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临床试验/NCT02234219
NCT02234219已完成不适用

Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2019年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
177
试验地点
1
主要终点
bowel function score

研究概览

简要总结

Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.

详细描述

At present, the treatment for children with HSCR is still surgery. The basic treatment principles of all surgical procedures commonly used in the world include confirming the location of the transitional zone between the intestinal tube with and without ganglion cells, removing the intestinal segment without ganglion cells, and reconstructing the digestive tract by anastomosis of the intestinal segment with ganglion cells with the anus or rectum. Intact anal receptors and autonomic internal sphincter control are essential for autonomic bowel control, and the integrity of the internal sphincter directly affects the occurrence of soilage and fecal incontinence after surgery. Therefore, how to deal with the internal sphincter during the operation, so as to avoid the recurrence of constipation caused by the spasm of the internal sphincter after the operation, and to retain the function of the internal sphincter for defecation control has been the focus of research.

In the 1980s, Professor Wang Guo, based on the experience of previous researchers, innovated the "heart-shaped anastomosis", which is a surgical procedure in which the dorsal rectum is split longitudinally to the dentate line without removing the internal sphincter, and then the normal colon is drawn out to make an oblique anastomosis with the rectoanal canal. A retrospective single-center follow-up of nearly 100 cases of "heart-shaped anastomosis" over a period of 20 years found that compared with traditional end-to-end colorectal anastomosis, patients with "heart-shaped anastomosis" had a significantly lower rate of fecal fouling and a long-term Bowel function score (Bowel function score, bowel function score). BFS) and Quality of Life-BREF (QLB) were also significantly improved compared with the traditional operation (P<0.05), and no other adverse events occurred. This study aims to determine the optimal surgical procedure for HSCR by a prospective, multicenter controlled study comparing the "heart-shaped anastomosis" with the commonly used Soave procedure.

In summary, this project will compare the application of "heart-shaped anastomosis" and traditional surgery for children with HSCR before operation, and comprehensively evaluate the advantages of "heart-shaped anastomosis" for defecation control from morphology to electrophysiological function through postoperative follow-up, combined with anorectal manometry.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None (Participant)

入排标准

年龄范围
3 Months 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age<14 years
  • •Hirschsprung's disease diagnosed by biopsy
  • •Surgical indication

排除标准

  • •Age>14 years
  • •Not Hirschsprung's disease
  • •Surgical contraindication

研究组 & 干预措施

Heart-shaped anastomosis

Experimental

Heart shaped anastomosis

干预措施: Heart-shape anastomosis (Procedure)

Circle anastomosis

Active Comparator

Soave anastomosis

干预措施: Soave anastomosis (Procedure)

结局指标

主要结局

bowel function score

时间窗: 2 years

Ability to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem

次要结局

  • bowel function score(1 month/6 month/12 month)
  • rate of postoperative complication(1month/6 month/12 month/2 years)
  • rate of reoperation(1month/6 month/12 month/2 years)
  • rate of readmission(1month/6 month/12 month/2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiexiong Feng

Professor

Tongji Hospital

研究点 (1)

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